36698 Federal Register / Vol. 63, No. 129 /Tuesday, July 7, 1998 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Health Care Policy and

Research

General Reorganization; Statement of

Organization, Functions, and

Delegations of Authority

Part E, Chapter E (Agency for Health

Care Policy and Research), of the

Statement of Organization, functions,

and Delegations of Authority for the

Department of Health and Human

Service (61 FR 15955–58, April 10,

1996, and 62 FR 61511–12, November

18, 1997) is amended to reflect

organizational changes within the

Agency for Health Care Policy and

Research (AHCPR). This action is

necessitated by a reordering of Agency

priorities and the need to more

effectively align and utilize Agency

resources. The principal organizational

and functional changes required by this

action involve:

A. Abolishing the Office of Planning

and Evaluation, with certain functions

being reassigned to other components in

AHCPR;

B. Abolishing the Center for

Information Technology, with a limited

number of its functions absorbed by

other components of the Agency;

C. Retitling the Office of Scientific

Affairs to be more reflective of

expanded functions, and;

D. Establishing a staff-level office

within the Office of the Administrator to

carry out the functions of the Center for

Health Information Dissemination,

which will subsequently be abolished

by this action.

Other minor changes have been made

consistent with this reorganization.

Under Section E–10, Organization,

delete entries A. through M. and insert

the following:

A. Immediate Office of the

Administrator

B. Office of Management

C. Office of Policy Analysis

D. Office of Research Review,

Education, and Policy

E. Office of Health Care Information

F. Center for Cost and Financing Studies

G. Center for Organization and Delivery

Studies

H. Center for Outcomes and

Effectiveness Research

I. Center for Primary Care Research

J. Center for Quality Measurement and

Improvement

K. Center for Practice and Technology

Assessment

Under Section E–20, Functions, delete

the titles and statements for the Office

of Planning and Evaluation (EAB), the

Office of Scientific Affairs (EAE), the

Center for Health Information

Dissemination (EF), and the Center for

Information Technology (EG).

Within the statement for the

Immediate Office of the Administrator

(EA), delete (2) and insert the following:

‘‘(2) plans, directs, coordinates, and

evaluates the Agency’s research,

training programs, and dissemination

activities, including particular focus

areas, such as special populations,

initiatives, and administrative policies

and procedures;’’.

Within the statement for the Office of

Policy Analysis (EAC), make the

following changes:

Delete (6) and insert the following:

‘‘(6) coordinates the legislative activities

of the Agency including the

development of legislative proposals

and analysis of health legislative

initiatives, and reports to Congress;’’

Following (8), insert the following:

‘‘(9) coordinates review and clearance of

Department and other Federal policies

and regulations; and’’ and renumber the

old (9) as (10).

Following the statement for the Office

of Policy Analysis (EAC), insert the

following:

Office of Research Review, Education,

and Policy (EAE). Directs the scientific

review process for grants and Small

Business Innovation Research (SBIR)

contracts, the assignment of

applications to Agency Centers,

manages Agency research training

programs, and evaluates the scientific

contribution of proposed and on-going

research, demonstrations, and

evaluations. Specifically: (1) directs the

process for selecting, reviewing, and

funding grants and reviewing SBIR

contracts for scientific merit and

program relevance; (2) assigns grant

applications to Centers for

administrative action; (3) manages the

process for making funding decisions

for grants; (4) directs Agency research

training programs and implementation

of the National Research Service Award

authority; (5) manages the committee

management and scientific integrity

processes for the intramural and

extramural programs of the Agency; (6)

develops and coordinates clearance of

peer review regulations, as required,

policy notices and program

announcements; (7) facilitates Agencywide communication and coordination

regarding extramural policy, planning,

and analysis; and (8) represents the

Agency in meetings with experts and

organizations on issues related to the

administration of the Agency’s scientific

programs.

Office of Health Care Information

(EAF). Designs, develops, implements,

and manages programs for

disseminating the results of Agency

activities. Specifically: (1)

Communicates the results and

significance of health services research

and other AHCPR initiatives to the

health care industry, health care

providers, consumers and patients,

policy makers, researchers, and the

media with particular emphasis on

communicating AHCPR initiatives in

the ways each of these constituencies

are most interested; (2) manages the

editing, publication, and information

distribution processes of the Agency,

including Freedom of Information Act

administration; (3) provides the

administrative support for reference

services and the distribution of

technical information to Agency staff;

(4) manages the public affairs activities

of the Agency, Agency clearinghouse for

responding to requests for information

and technical assistance, and a program

for consumer information about health

care research findings; (5) directs a user

liaison program to provide health care

research and policy findings to Federal,

State and local public officials, and

other audiences as appropriate; (6)

evaluates the effectiveness of Agency

dissemination strategies and

implements changes indicated by such

evaluations; and (7) represents the

Agency in meetings with Department

and Public Health Service

representatives on press releases, media

events, and publication clearance.

All delegations and redelegations of

authority to officers and employees of

the Agency for Health Care Policy and

Research which were in effect

immediately prior to the effective date

of this reorganization shall continue in

effect pending further redelegation,

provided they are consistent with this

reorganization.

These changes are effective upon date

of signature.

Dated: June 18, 1998.

John M. Eisenberg,

Administrator.

[FR Doc. 98–17923 Filed 7–6–98; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Clinical Laboratory Improvement

Advisory Committee (CLIAC): Meeting

Name: CLIAC, Workgroup on Genetic

Testing.

Times and Dates: 8:30 a.m.–5 p.m., July 30,

1998; 8:30 a.m.–5 p.m., July 31, 1998.
Federal Register / Vol. 63, No. 129 /Tuesday, July 7, 1998 / Notices 36699

Place: CDC, Koger Center, Williams

Building, Conference Rooms 1802 and 1805,

2877 Brandywine Road, Atlanta, Georgia

30341.

Status: Open to the public, limited only by

the space available. The meeting rooms

accommodate approximately 85 people.

Purpose: This workgroup advises CLIAC

on issues related to Genetic Testing.

Matters to be Discussed: The workgroup

will discuss and revise recommendations for

general or specific Clinical Laboratory

Improvement Amendments (CLIA)

requirements for pre-analytic, analytic, and

post-analytic components of genetic testing.

Agenda items are subject to change as

priorities dictate.

Contact Person for Additional Information:

John C. Ridderhof, Dr. P.H., Division of

Laboratory Systems, Public Health Practice

Program Office, CDC, 4770 Buford Highway,

NW Mailstop G–25, Atlanta, Georgia 30341,

telephone 770/488–8076, FAX 770/488–

8282.

Dated: June 26, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–17917 Filed 7–6–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Meeting

National Institute for Occupational

Safety and Health (NIOSH) of the

Centers for Disease Control and

Prevention (CDC) announces the

following meeting.

Name: Laboratory Evaluation of Novel

Personal Heat Strain Monitors in Young and

Older Wearers of Protective Clothing.

Time and Date: 1 p.m.–3:30 p.m., July 21,

1998.

Location: NIOSH, CDC, Room H–203, 1095

Willowdale Road, Morgantown, WV 26505.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 35 people.

Purpose: Participants will provide NIOSH

with their individual advice and comments

regarding the technical and scientific aspects

of the study protocol, A Laboratory

Evaluation of Novel Personal Heat Strain

Monitors in Young and Older Wearers of

Protective Clothing, being conducted at

NIOSH. Participants on the peer review panel

will review the study protocol and provide

individual advice on the conduct of this

study. Viewpoints and suggestions from

industry, labor, academia, other

governmental agencies, and the public are

invited.

Contact Person for Additional Information:

Nina L. Turner, NIOSH, CDC, M/S 35, 1095

Willowdale Road, Morgantown, West

Virginia, 26505–2888, telephone 304/285–

5976.

Dated: June 30, 1998.

Carolyn J. Russell.

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–17916 Filed 7–6–98; 8:45 am]

BILLING CODE 4160–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0492]

ICI PLC; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that ICI PLC has filed a petition

proposing that the food additive

regulations be amended to provide for

the expanded safe use of N,N-bis (2-

hydroxyethyl) alkyl (C13-C15) amine as

an antistatic agent in polypropylene

homo- and copolymers intended for

contact with food.

FOR FURTHER INFORMATION CONTACT:

Ellen M. Waldron, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3089.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5)),

notice is given that a food additive

petition (FAP 8B4602) has been filed by

ICI PLC, c/o ICI Surfactants, P.O. Box

8340, Wilmington, DE 19803–8340. The

petition proposes to amend the food

additive regulations in § 178.3130

Antistatic and/or antifogging agents in

food-packing materials (21 CFR

178.3130) to provide for the expanded

safe use of N,N-bis (2-hydroxyethyl)

alkyl (C13-C15) amine as an antistatic

agent in polypropylene homo- and

copolymers intended for contact with

food.

The agency has determined under 21

CFR 25.32(i) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: June 17, 1998.

Linda M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–17877 Filed 7–6–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Team Biologics; Workshop for

Manufacturers of Licensed In Vitro

Diagnostics

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA), Center for Biologics Evaluation

and Research (CBER) and the Office of

Regulatory Affairs (ORA) is announcing

the following workshop for the biologics

industry: Team Biologics: Workshop for

Manufacturers of Licensed In Vitro

Diagnostics. The topics to be discussed

include information for manufacturers

of licensed in vitro diagnostics on team

biologics, good manufacturing practices,

and compliance and enforcement issues.

Questions submitted by industry prior

to the workshop will be addressed by

FDA staff.

Date and Time: The workshop will be

held on Friday, August 7, 1998, 8 a.m.

to 5 p.m.

Location: The workshop will be held

at the Hyatt Regency Bethesda, One

Bethesda Metro, Bethesda, MD 20814,

301–657–6406.

Contact: Kathy A. Eberhart, Food and

Drug Administration, Center for

Biologics Evaluation and Research

(HFM–49), 1401 Rockville Pike, suite

200N, Rockville, MD 20852–1448, 301–

827–2000, FAX 301–827–3079, e-mail

‘‘eberhart@cber.fda.gov’’.

Registration: Fax registration

information (including name, title, firm

name, address, telephone, and fax

number) and questions to the contact

person by Friday, July 24, 1998. There

is no registration fee for the workshop.

Space is limited, therefore interested

parties are encouraged to register early.

If you need special accommodations

due to a disability, please contact Kathy

A. Eberhart at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA has

established a framework for a

partnership between ORA and CBER

called Team Biologics. This partnership

will use the diverse skills and

knowledge of both ORA and CBER staffs

to focus resources on inspectional and

compliance issues in the biologics area.